Clinical Performance of a Highly-filled Flowable Composite in Class III Restorations.

NCT07051551 | Active Not Recruiting

• 1 other identifier: KA-24010
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study was to evaluate the 12-month clinical performance of a highly filled flowable composite resin in anterior teeth. The study will include healthy individuals over the age of 18 who apply to the Department of Restorative Dentistry, Faculty of Dentistry, Hacettepe University, for the treatment of Class III lesions in their anterior teeth. After explaining the purpose and procedures of the study, participants will be asked to sign an informed consent form if they agree to participate. Gender, age, and the tooth numbers to be treated will be recorded. A total of 100 maxillary anterior incisor teeth in 50 patients will be treated, ensuring a balanced distribution of treated teeth between the right and left arches. A split-mouth design will be used, whereby at least two teeth per patient will be included in the study, and each of the two restorative materials will be applied to one tooth. The allocation of restorative material to each tooth will be randomized. Before the procedure, the names of both materials will be written on separate papers, placed into envelopes, and a member of the auxiliary staff will randomly select one envelope during the restoration stage to ensure randomization. The sample size was calculated using the Sealed Envelope software program (Sealed Envelope Ltd., 2012). It was assumed that 95.0% of the restorations would remain intact over 12 months, with α = 0.05, power = 80%, and an expected 10% difference between groups. Based on these parameters, the required sample size was calculated as 33. Considering the possibility of patient dropout during the study, 50 teeth per group were included.

Conditions

Dental Caries

Keywords

dental caries; highly filled flowable resin composite; class ııı restorations

Outcome Measures

Primary Outcomes (1)

• Retention alpha for at least %90 of the restorations

  The primary endpoint was the assessment of restoration retention and absence of material fracture, evaluated according to the FDI World Dental Federation clinical criteria. A restoration was considered successful if it received a score of 1 (excellent) or 2 (good) and remained in place without the need for repair or replacement.

  1 year

Study Arms (2)

highly filled flowable resin composite

EXPERIMENTAL

After etching the enamel with 37% phosphoric acid for 30 seconds, the area will be rinsed with water for 20 seconds and gently air-dried. One layer of adhesive (G2 Bond, GC Corp, Tokyo, Japan) will be applied according to the manufacturer's instructions and polymerized for 10 seconds with a LED light curing unit.The injectable composite resin (G-Aenial Universal Injectable) will be placed similarly in 2 mm increments and light-cured.

Device: tooth restoration

conventional resin composite

ACTIVE COMPARATOR

After etching the enamel with 37% phosphoric acid for 30 seconds, the area will be rinsed with water for 20 seconds and gently air-dried. One layer of adhesive (G2 Bond, GC Corp, Tokyo, Japan) will be applied according to the manufacturer's instructions and polymerized for 10 seconds with a LED light curing unit. Conventional composite resin (G-Aenial A'chord) will be placed in increments of no more than 2 mm, each layer light-cured.

Device: tooth restoration

Interventions

tooth restoration DEVICE

restoration of class ııı cavities

conventional resin composite

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Be at least 18 years of age.
• Have at least two Class III lesions in maxillary anterior teeth.
• Lesions must be classified as D2 (involving half the dentin thickness) and must not extend to D3 (three-quarters dentin depth).
• Must provide signed informed consent.
• Be physically capable of attending all follow-up appointments.
• Have no periapical pathology in the involved teeth.

You may not qualify if:

• Presence of severe periodontal disease affecting the tooth planned for restoration.
• Absence of an opposing tooth or lack of occlusal function involving the affected tooth.
• Subgingival extension of the lesion beyond the cervical margin.
• Lesions limited to enamel without dentinal involvement.
• Extensive lesions that cannot be restored with a direct restorative technique.
• Presence of anterior malocclusion affecting tooth positioning or function.
• Individuals with intellectual disabilities that may impair communication or compliance.
• Teeth that have been previously restored in the area of interest.
• Known allergy to methacrylate monomers or methacrylate-based polymers.
• Patients under the age of 18 or over the age of 64.

Sponsors & Collaborators

• Hacettepe University: lead

Study Sites (1)

Hacettepe University

Ankara, 06530, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: research assistant

Model Details: randomized controlled clinical trial

Study Record Dates

• First Submitted: June 26, 2025
• First Posted: July 4, 2025
• Study Start: October 1, 2024
• Primary Completion: December 1, 2025
• Study Completion (Estimated): December 1, 2026
• Last Updated: July 4, 2025

Record last verified: 2025-06

Locations

TU (1)